Adjustable seal system, seal component and method for using the same

ABSTRACT

An adjustable seal system, seal component for use in the system, and method are provided for forming a sealing interface between a residual limb and a prosthetic socket. The seal component is selectively placed over the outer surface of a suspension liner including a plurality of seal bands, which the seal component may removably and securely engage.

CROSS REFERENCE TO RELATED APPLICATIONS

This application incorporates by reference the following U.S. patentapplications and patents: U.S. application Ser. No. 13/179,896, filed onJul. 11, 2011, which is a continuation of U.S. patent application Ser.No. 11/654,549, filed on Jan. 18, 2007, now U.S. Pat. No. 8,034,120,which is a continuation-in-part of U.S. patent application Ser. No.11/516,500, filed on Sep. 7, 2006, now U.S. Pat. No. 7,909,884, which isa continuation-in-part of U.S. patent application Ser. No. 11/135,354filed on May 24, 2005, now U.S. Pat. No. 7,749,281, which is adivisional application of U.S. patent application Ser. No. 10/690,545filed on Oct. 23, 2003, now U.S. Pat. No. 7,025,793, which claims thebenefit of priority from U.S. provisional application 60/434,669 filedon Dec. 20, 2002. U.S. patent application publication 2013/0053982,published on Feb. 28, 2013 is also incorporated by reference in itsentirety.

BACKGROUND

A. Field of the Disclosure

This disclosure relates to suspension liners adapted to provide aninterface between a residual limb and a prosthetic socket. Thedisclosure provides various embodiments of an adjustable seal system,seal components for use in the system, and methods for providing asealing interface between a residual limb and a prosthetic socket.

B. Discussion of Related Art

Suspension liners provide a soft, flexible interface between a residuallimb of an amputee and a hard socket to which a prosthetic device issecured. Such liners are known in the art generally, as exemplified byU.S. Pat. No. 4,923,474 granted May 8, 1990 to Klasson and Kristinsson.These liners are typically made of an air impermeable elastomer materialsuch as silicone and may include a reinforcement layer intermediate theinner and outer surfaces of the liner body portion or externally thereofto provide resistance against axial elongation of the elastomerconstituting the liner body. Such reinforcement typically does notrestrict radial distension or stretching of the liner body.

The liners may also include an outer covering different from theelastomeric material, and exemplary outer coverings include varioustextiles having different stretchability properties. For example, theouter cover may be a strong and stretchable nylon outer cover providingresistance to extreme wear and tear, and affording strength anddurability. The nylon outer cover may be used to increase radial stretchand comfortable elasticity.

In the prior art, liners may function to secure the residual limb withina prosthetic socket once the residual limb and sleeve are inserted intothe socket in close-fitting relationship by isolating the distal endarea of the hard socket from the atmosphere. Upon application of apulling force on the liner relative to the socket, suction is created inthe distal end of the socket tending to retain the liner within thesocket. Appropriate devices are usually provided to enable expulsion ofair between the distal end of the liner and the hard socket, and toisolate the distal end of the hard socket member from the atmosphereafter the liner with a residual limb has been fully inserted within thesocket member.

In some applications, the liner is provided with an umbrella at itsdistal end and a threaded socket for receiving a prosthetic securing pinmember which then extends through an axial opening in the distal end ofthe hard socket member for securing the socket member relative to aprosthetic device mounted to the distal end of the socket member. Inother applications, the prosthetic device is secured to the exterior ofthe distal end of the hard socket member and the sleeve member is fullycontained within the hard socket member.

The elastomer constituting the liner may be arranged to frictionallyengage and remains attached to the skin of a residual limb so that thelimb is retained within the hard socket member in a comfortable,non-irritating manner. The liner may be thickened to provide cushioningeffect between the residual limb and the hard socket, which is typicallycustom made to closely fit the residual limb. Liners of this kind areused for both trans-tibial (TT) amputees as well as trans-femoral (TF)amputees. That is, the liners may be utilized for applications above theknee or below the knee of the amputee.

In other applications, it may be desired to more positively secure theliner within the socket by creating a hypobaric (vacuum) pressure withinthe distal end of the hard socket between such distal end and the distalend of a liner inserted into the socket with a residual limb containedwithin the liner. The hypobaric pressure may be maintained at the distalend of the hard socket and the interior of the socket at its distal endwill be isolated from atmosphere during normal retention of the sleeveliner within the socket. Opening the distal end of the socket toatmosphere releases the vacuum or hypobaric pressure within the socketto enable simple withdrawal of a residual limb with a liner thereon fromthe socket.

A pump or other device may be utilized to evacuate the distal end of thesocket between the distal end of a liner and the distal end of a socket.A valve or other appropriate device typically is used to open and closethe distal end of a socket to surrounding atmosphere.

Various arrangements are known in the prior art for providing anappropriate seal between the exterior of the liner and the interior ofthe hard socket including external air impermeable sleeves covering theinterface area between the proximal end of the hard socket and theadjacent liner body.

In trans-femoral applications, the sealing between a sleeve and a socketis generally simpler and easier to execute than sealing a trans-tibialliner against the inner surface of a socket because in the lattersituation, the residual limb contains more bony protuberances andirregular shapes that are difficult to effectively seal, particularly ifit is desired to simply use the material of the elastomeric liner as thesealing element.

Some users find that known liners having sealing means fail tosufficiently tolerate volume fluctuations, and may leave pressure markson the residual limb after periods of sustained use. Additionalimprovements may be required for some users in that known liners do notadequately conform to the user's anatomy, and therefore fail to providenecessary comfort and skin protection. Moreover, as with all suspensionliners having sealing means, it is necessary that the liner providesreliable suspension after an initial phase of volume and shapeconditioning after the liner is donned on the user's residual limb.

SUMMARY

The disclosure provides various embodiments of an adjustable sealsystem, seal components for use in the system, and methods for providinga sealing interface between a residual limb and a prosthetic socket. Theembodiments are beneficial to address the challenges faced by amputeesby providing flexibility in placement of a seal component to avoidvarious pressure points and accommodate the shape of the residual limb.

According to an embodiment, the adjustable seal system includes asuspension liner defining a liner body forming an axis and having anouter surface including a plurality of seal bands located along theheight of the liner body. A seal component has open upper and lower endsdefining an opening therethrough and an internal surface having an axisarranged concentric with the axis of the liner body. The internalsurface is arranged to frictionally engage at least one of the pluralityof seal bands and secure on the outer surface of the liner body.

The liner preferably defines a closed-ended distal portion and the sealcomponent is adapted to be inserted onto the liner from the distalportion. The liner defines an open-ended proximal portion and theproximal portion preferably has a greater diameter than the distalportion. Alternatively, the liner may have a consistent diameter abovethe distal portion, and along middle and proximal portions of the liner.A diameter of the opening of the seal component may be less than thediameter of the proximal portion.

The at least one seal band may be formed from a polymeric material andthe outer surface of the liner body may be defined by a textile-basedcover. The at least one seal band may be formed so as to bleed or wetthrough a textile of the textile-based cover and interlock therewith.

In an embodiment of the seal component, an upper portion may havesegment with a curvature descending to a seal. A lower portion may havea segment curvingly ascending to the seal. The seal may extend from thelower portion and a distance beyond the periphery of the curvature. Theupper portion may define a recess formed by the periphery of thecurvature proximate the seal. A bevel preferably delimits a top portionof the recess from the curvature. The lower portion may define aplurality of ribs circumferentially extending around the periphery ofthe lower portion. The ribs may be arranged along the height of thelower portion.

The seal may be arranged to protrude away from the outer surface of theliner body. The seal may be arranged to collapse against the outersurface when placed and engaging a socket, essentially losing thedistance.

The seal may form a flap protruding away from an upper portion of theseal component a predetermined distance while having a base intersectingwith the upper curvature. The upper portion may define a recess formedby the periphery of the curvature proximate the seal. A bevel maydelimit a top portion of the recess from the curvature. The flapgenerally has a size corresponding to the recess such that uponinsertion into a socket, the flap is urged into the recess, and has anend portion abutting the bevel. The upper and lower portions generallyintersect at a base of the flap.

The seal component may define interior blades located along the interiorsurface and correspond in location to the seal located on the exteriorside of the seal component. The interior blades may be arranged in avariety of different formations, and are preferably at an angle orientedobliquely relative to the axis of the seal component.

The seal component is not limited to the embodiments discussed above butmay be arranged in a variety configurations with an interior arrangementto secure against a liner body of a suspension liner and an exteriorarrangement to secure against a surface of socket for providing asealing interface between a residual limb and a prosthetic socket.

The adjustable seal system may include a textile sleeve secured to anupper portion of the seal component and arranged to radially compressagainst the outer surface of the liner. The textile sleeve is preferablyan anatomical conforming fabric. The textile provides an interface forgripping, and thereby minimizing fine hand movement needed to don andadjust the seal component over the liner. The sleeve is preferably moreflexible and elastic than the seal component such that the sleeveretracts to an original size upon release of tension of the sleeve. Thesleeve has a diameter less than a diameter of the liner body at thedistal portion such that the sleeve stretches over and is tensioned whenselectively placed over the outer surface of the liner body. The sleeveincludes a main portion having a first elasticity, and a top bandlocated at an upper end of the main portion and having a secondelasticity.

Whether alone or in combination with the textile sleeve, the sealcomponent may define a body forming an interior surface arranged to spana distance between at least two seal bands and engage therewith. A sealmay be located below an upper portion and above a lower portion whereinthe upper portion is generally concentric with the liner body and theseal protrudes radially outwardly from the axis relative to the upperportion. The seal may have a radially outermost portion arrangedgenerally concentric with the upper portion. The seal may have a lowersegment extending outwardly from the lower portion to the radiallyoutermost portion.

The seal may have an upper segment extending inwardly from radiallyoutermost portion toward the upper portion. A clearance is definedbetween the upper portion and the upper segment such that the seal isarranged to be compressed against the upper portion. The seal can definea flap extending from the upper segment. The flap is arranged generallyparallel with the upper portion and spaced from the upper portion by theclearance.

The seal component includes a seal located below an upper portion andabove lower portion. The seal has a lower segment extending outwardlyfrom the lower portion to a radially outermost portion and at least oneradial seal projecting outwardly from the lower segment. The sealcomponent includes a seal located below an upper portion (602) and abovea lower portion and having a radially outermost portion spaced by aclearance from the upper portion. The seal component has a lower portiondefining a curvature and an upper portion having a substantially uniformdiameter along its height. The lower portion has a decreasing diametertoward the lower end.

In any of the embodiments, the at least one seal band may be formed froma polymeric material and the outer surface of the liner body is definedby a textile cover. The at least one seal band extends through thetextile cover and interlocks therewith. Locating indicia may be providedbetween each of the seal bands.

In a method for placing a seal component on a suspension liner andsecuring therewith, the method may include the steps of: providing aliner having a liner body forming an axis and having an outer surfaceincluding a plurality of seal bands located along the height of theliner body and an outer surface of the liner body; placing a sealcomponent having open upper and lower ends defining an openingtherethrough and an internal surface having an axis arranged concentricwith the axis over the liner; and securing the seal component to theliner body by frictionally engaging the internal surface with at leastone of the plurality of seal bands.

BRIEF DESCRIPTION OF THE DRAWINGS

The numerous other advantages, features and functions of embodiments ofa suspension liner will become readily apparent and better understood inview of the following description and accompanying drawings. Thefollowing description is not intended to limit the scope of thesuspension liner, but instead merely provides exemplary embodiments forease of understanding.

FIG. 1 is a perspective view showing an embodiment of a liner having amovable seal system.

FIG. 2 is a perspective view showing the liner of FIG. 1 without a sealcomponent.

FIG. 3 is a detailed view showing concentric seal bands disposed aboutan outer cover of the liner body.

FIG. 4 is a detailed view showing a spiral configuration of seal bandsdisposed about an outer cover of the liner body.

FIGS. 5 a and 5 b are schematic views showing various surface texturesof a liner body.

FIG. 6 is a schematic view of a seal component having a single fin.

FIG. 7 is a schematic view of a seal component having a plurality offins.

FIG. 8 is a schematic view of a seal component having a plurality offins.

FIG. 9 is a schematic view of a seal component having a plurality offins.

FIG. 10 is a cross-section of another seal component having a pluralityof fins.

FIGS. 11 and 12 are schematic views showing a seal component having afolding structure.

FIGS. 13 and 14 are schematic views showing a seal component having arippled edge portion.

FIGS. 15 and 16 are schematic views showing a seal component having acolor indicator.

FIG. 17 is a schematic view showing a seal component having a lower fin.

FIG. 18 is a schematic view showing a seal component having a pluralityof lower fins.

FIG. 19 is a schematic view showing a seal component having a pluralityof proximal handles.

FIG. 20 is a schematic view showing another seal component having aplurality of proximal handles.

FIG. 21 is an elevational view of another seal component having acollapsible seal.

FIG. 22 is a cross-section taken along line XXII-XXII from FIG. 21.

FIG. 23A is an elevational view showing an embodiment of a suspensionliner with a plurality of seal bands.

FIG. 23B is an elevational view showing a cross-section taken along lineXXIII B-XXIII B.

FIG. 24A is an elevational view of the suspension liner of FIG. 23A withthe seal component of FIG. 21.

FIG. 24B is a detail view taken from XXIV B in FIG. 24A.

FIG. 24C is a detail view taken from XXIV C in FIG. 24A.

FIG. 25A is perspective view of another seal component having acollapsible seal and interior fins.

FIG. 25B is a cross-sectional view taken along line XXV-XXV A from FIG.25A.

FIG. 26A is a schematic cross-sectional view of a variation of the sealcomponents of FIGS. 21 and 25A.

FIG. 26B is a detail view taken from XXVI B in FIG. 26A.

FIG. 27 is an elevational view of a seal component having a textileportion.

FIG. 28A is an elevational view of the suspension liner of FIG. 23A withthe seal component of FIG. 27.

FIG. 28B is a detail view taken from XXVIII A in FIG. 28A.

FIG. 29A is a sectional view taken along line XXIX A-XXIX A in FIG. 27.

FIG. 29B is a detail view taken from XXIX B in FIG. 29A.

FIG. 30A is a perspective view of another seal component embodiment.

FIG. 30B is a sectional view taken along line XXX B-XXX B in FIG. 30A.

FIGS. 31A-31E show methods for donning the adjustable seal system ofFIG. 24A.

It should be noted that the drawing figures are not necessarily drawn toscale, but instead are drawn to provide a better understanding of thecomponents thereof, and are not intended to be limiting in scope, butrather to provide exemplary illustrations. It should further be notedthat the figures illustrate exemplary configurations of a liner, and inno way limit the structures or configurations of a liner thereofaccording to the present disclosure.

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS

A better understanding of different embodiments of the invention may behad from the following description read in conjunction with theaccompanying drawings in which like reference characters refer to likeelements.

A. Overview of Suspension Liner Embodiments

In each of the embodiments discussed herein, the suspension liner isintended for use between a residual limb and a prosthesis, such as ahard socket, and to be air-tight when donned over a residual stump. Theinternal surface of the liner may be formed of a layer of siliconeelastomer, therefore serving as a skin interface.

Silicone is advantageous in that it allows for different levels andsoftness and strength to be incorporated into the liners of the presentapplication. Moreover, silicone permits the addition of selectedsupplements, such as petroleum jelly and aloe vera, which improve skincare and comfort. The suspension liner, however, can be constructed froma variety of other materials other than from silicone, and theembodiments herein are not limited to suspension liners formed fromsilicone.

An elasticity controlling matrix material may be provided on theexterior of the liner, the matrix material preferably being relativelycompliant in a radial direction and substantially rigid or inelastic inan axial direction. The matrix material may extend over the distal orexternal side of the prosthesis, and is advantageous in that it preventsmovement of the liner when a prosthesis is worn thereover.

A liner in accordance with this disclosure may be fabricated in asufficient number of sizes to accommodate various sizes of residuallimbs. In use, a liner of the type described herein is rolled up fromthe proximal to the distal end, placed over the distal end of theresidual stump and rolled back up or “donned” over the stump like astocking This procedure and the benefits achieved thereby are describedin detail in U.S. Pat. No. 4,923,474, granted on May 8, 1990 andincorporated herein by reference. In addition, any of the liners andsleeves mentioned herein may be constructed in the manner prescribed byU.S. Pat. No. 4,923,474.

The embodiments of the suspension liner of the present application maybe constructed according to the molding methods described in U.S. Pat.No. 6,485,776, granted on Nov. 26, 2002 and the entirety of which isincorporated herein by reference.

B. Operation of a Seal Component in Combination with a Suspension Linerand Prosthetic Socket

As taught in U.S. patent application publication 2013/0053982, in use aliner carrying a seal component is worn on a residual limb and steppedinto a prosthetic socket. As the residual limb is placed into thesocket, the seal component forms an airtight seal with an interiorsurface of the socket and urges air out of the distal end of the socketthrough a distally positioned expulsion valve. When it is desired torelease the connection between the liner and the socket, the valve isreleased, and the residual limb can be removed from the socket.

When sealing against a socket, it should be kept in mind that the vacuumis formed between the seal component and the distal end of the socket;no vacuum is created proximal of the socket between the liner and thesocket. Depending on configurations of the seal component, the sealcomponent may not completely press against the socket wall, in that onlyportions of the seal press against the socket wall. For example, sealrings of the seal component may press against the socket wall, butportions between the seal rings may not touch the socket wall.

Pressure is inversely proportional to the suspension force needed, so asto ensure stability and rotational control. The seal componentpreferably forms a hypobaric sealing membrane that conforms to the shapeof the internal socket wall, providing an airtight seal between thesuspension liner and the socket. It is often desirable that evenpressure exists around the seal component in the connection between thesocket and liner. There is preferably firm suspension among the liner,socket and residual limb.

C. Embodiments of Adjustable Seal Systems, Seal Components and Methodsfor Using the Same

In observing the suspension liner embodiment of FIGS. 1 and 2, the liner10 includes a liner body 12 defining an internal cavity 14 for receivinga residual limb. The liner body 12 preferably has an elongate, generallyconical shape, and defines a longitudinal axis A-A along which extendproximal and distal portions 16, 20 spaced apart by a middle portion 18.The liner body 12 may be formed from at least one material segment thatis at least radially elastically extensible from a relaxed non-extendedcondition.

A seal component 22 is secured to an outer surface of the liner body 12among an at least one seal band 26 formed along the outer surface of theliner body. In this embodiment, the at least one seal band 26 definesthree seal rings 28, 30, 32 located about a circumference of the middleportion 18. The seal rings may be formed from a frictional material tomaintain the seal component 22 on the liner. An example of a frictionalmaterial is silicone, however other suitable materials may be used. Theseal component 22 frictionally fits against at least one of the sealrings, and can be installed among any one of the seal rings, along thelength of the liner body. The seal component 22 can likewise be removedfrom the liner body and readjusted as considered necessary at a newlocation.

In this embodiment, the seal component is considered detachable in thatit can be removed from liner body with destruction, and adjustable so asto be reappointed on the liner body without any adhesive or permanency.According to a desired height of the seal component, the seal componentcan be installed among any one or more of the seal rings.

Various advantages are provided by this embodiment over known sealsystems. The adjustable seal component can be placed proximally ifdesired to permit vacuum over the majority of the outer surface of theliner body to maximize suspension potential. The adjustable sealcomponent can be arranged on the liner body outer surface to avoidsensitive areas, for example neuromas or scar tissue, to afford the usermore comfort over systems where the seal component is at a fixedlocation.

The impact of volume fluctuations can be mitigated by placement of theseal component at an ideal location for a given user. For example,moving the seal component toward the proximal end of the liner body maycompensate a decrease in volume. Further yet, donning and doffing of theliner is made easier. The liner may be inverted and rolled onto theresidual limb without the seal component, and the seal component is onlyinstalled after the limb is donned on the residual limb.

The at least one seal band may take on a variety of configurations andis not limited to the configuration shown in FIGS. 1 and 2. The at leastone rib may be circumferentially segmented over the outer surface, andmay take on a variety of thickness and shapes.

In an exemplary method of manufacturing the at least one seal bandformed from silicone or other polymeric material on a textile-basedouter surface or cover, the silicone rib is formed so as to bleed or wetthrough the textile and interlock therewith.

Various types of materials may be used to form the at least one sealband. In the disclosed embodiments, a silicone is selected having lowviscosity. Various patterns may be formed as the at least one rib toreduce or eliminate any flow of silicone deposited onto the outer cover.Various yarn types may be selected as a basis in which silicone isencouraged or allows to wet or bleed through the textile, as well ascertain weaves of the textile which facilitate wetting or bleeding ofthe material forming the at least one rib.

In observing FIG. 3, a plurality of individual rings 34 extends aboutthe circumference of the liner body 12. Each ring is spaced a distance36 from one another at specific increments which may be uniform ornon-uniform, such as with variable distances. The liner body 12 may alsoform protruding rings 35, 37 at distal and proximal ends delimiting theplurality of individual rings 34.

FIG. 4 offers a variation of a plurality of rings 38 continuouslyspiraling along the outer cover. This variation permits rings 38 havingdifferent widths and spacing, however each of the rings is continuouslyformed with another thereby continuously spiraling along the length ofthe outer cover. Of course, individual rings may be formed, such as inthe embodiment of FIG. 3 having different widths, and spacing among oneanother without necessarily spiraling along the length of the linerbody.

The at least one rib of any of the embodiments may protrude outwardlyfrom the outer cover at various depths, and embodiments may include aplurality of ribs extending along the entirety of the liner body or onlyalong certain segments. The profile of the at least one rib may beconfigured to correspond to an interior portion of the seal component,for example the profile of the at least one rib may form a profilemating a cavity along the interior surface of the seal component.

In addition to the at least one rib, various patterns of a frictionalmaterial, such as silicone, can be deposited on the outer textile coverto achieve various benefits. One benefit includes rotational control,which is obtained by patterns of the frictional material on the outercover to minimize rotational movement of the liner relative to thesocket. In another benefit, a frictional material may serve to controlor fine-tune characteristics of the liner. For example, the addition ofsilicone rings may serve to decrease radial stretch by inhibiting thestretchability of the outer cover and liner body by being formed from astiffer material. Alternatively, the rings may provide improved oradditional cushioning for stabilizing soft tissue areas in some regionswith wider, higher and/or more rings and patterns.

In another variation, the at least one rib may be colored to provideguidance to the user as to a desirable position of the seal component.For example, if the silicone rings were colored or shaped differentlyfrom one another, a user may be able to discern where to locate the sealcomponent. In yet another variation, a matting agent may be used todecrease the coefficient of friction of the at least one rib to improvedonning and doffing of the liner. In yet another variation, the surfacetexture of the at least one rib may be configured so the coefficient offriction is adapted to ease donning and doffing of the liner on a user.

The liner may be formed without an outer cover in that the liner body is“naked.” In such a naked liner, a matting agent may be used to decreasethe coefficient of friction along the outer surface of the liner. Theliner body may be formed as a dual durometer, as further explained inU.S. Pat. No. 6,136,039, granted on Oct. 24, 2000 and the entirety ofwhich is incorporated herein by reference.

Surface texturing may be provided on the surface of the liner, asexemplified in FIGS. 5 a and 5 b. For example, allowing airflow below aseal component to flow across the surface of the liner body and out or avalve. Different textures 40, 42 may be used along the outer surface ofthe liner body to achieve the necessary airflow.

D. Various Seal Components

Referring to FIG. 6, an embodiment of a seal component 50 includes aninner surface 52 arranged to abut a surface of the liner body. The sealcomponent 50 defines a ring portion 54 arranged for being flush againstthe liner body via the inner surface 52. A seal element 56 protrudesoutwardly relative to the ring portion 54 and is arranged to flexiblyengage the socket. An inner cavity 58 corresponding to seal element 56permits the seal element 56 to crush or compress inwardly upon donningof the socket. The inner cavity 58 may also mate with at least one ribof the liner. A ring portion may be provided on both upper and lowersides of the seal element.

FIG. 7 shows a seal component 60 similar to the embodiment of FIG. 6 butincludes a plurality of seal elements 68. The seal component 60 includesupper and lower ring portions 64, 66 spaced apart by the protruding sealelements 68. The seal component includes an interior surface 62 andinner cavities 70 corresponding to the seal elements 68.

FIGS. 8 and 9 exemplify embodiments of universal seal components definedin at least a first plane. The seal components are universal in thesense they may be placed onto a liner body in either direction and haveend portions generally symmetrical to one another. In other words, itdoes not matter the orientation the seal component is placed onto theliner body.

FIG. 8 shows seal component 80 having a plurality of seal elements 82generally concentric with one another. The first and second end portions84, 85 possess mirror image configurations so it does not matter as towhich end portion is placed on the liner body first and from whichdirection. The profile 86 of the seal elements may taper toward asubstantially flat middle seal element 88 as they span toward the endportions 84, 85 so as to facilitate donning with a socket.

FIG. 9 illustrates a seal component 100 having symmetrical end portions102, 103 defining a tapered profile for facilitating donning of asocket. The end portions 102, 103 are spaced a distance 104 from theseal elements 106, 107 protruding transversely and arranged forengagement with a socket wall. The seal elements are spaced apart fromone another a distance 108.

FIG. 10 exemplifies another seal component 120 that is universal in thesense it does not matter whether or not it is placed onto a liner bodyfrom either end direction or inside out. FIG. 10 shows a cross-sectionof such a seal component in that the seal component 120 has end portions122 symmetrical with one another, with seal elements 124 protrudinggradually greater transversely from both sides relative to the width ofthe seal component 128 until reaching a maximum protruding seal element126.

FIGS. 11 and 12 show a seal component 140 defining a folding structure.In this seal component 140, there are three concentric rings 142, 144,146, with the first ring 142 having the greatest circumference and thesecond and third rings 144, 146 having consecutively lesscircumferences. Due to the flexibility of the seal component 140, thesecond and third rings 144, 146 may fold into one another along foldlines 152. The interior of the seal component 140 may include at leastone cavity 148 for engaging at least one rib of the liner body, and mayinclude various protrusions 150 for engaging the liner body.

FIGS. 13 and 14 illustrate a seal component 160 having a pressure ortension indicator 164 along an upper portion 162. In this embodiment,the tension indicator 164 is defined as a rippled edge along the upperportion 162 and spaced from a lower seal element 166. When tensioned, asexemplified in FIG. 14, the tension indicator 164 straightens orpartially straitens. The tension indicator may indicate if there isexcessive or insufficient tension about the seal component.

FIGS. 15 and 16 provide a variation of a tension indicator on a sealcomponent 170. In this variation, the upper portion 172 includes acolored recess 174 that opens when the upper portion 172 is tensionedthereby exposing more color that is found in the recess. A seal element176 is provided below the colored recess 174.

FIGS. 17 and 18 show various seal components having one or multiple sealelements. FIG. 17 depicts a seal component 180 having an elongateportion 182 for extending about the liner body outer surface, and a sealelement 184 protruding from a lower end portion 186 of the sealcomponent. The seal element 184 extends outwardly from the lower endportion 186 at an angle and forms a tapering width 188 from the elongateportion 182. The seal component 180 is open at both upper and lower endsthereby forming an annular inner surface for securing about a linerbody.

FIG. 18 shows a variation of the seal component of FIG. 17 in that theseal component 190 of FIG. 18 includes a plurality of ribs 196 on theseal element 194. A user may employ different seal components or sealsizes for different activities. For example, the seal component of FIG.18 may be used for more aggressive sealing by way of the multiple ribs196 whereas the seal component of FIG. 17 may be used for lower activityusers.

Referring to the embodiment of FIGS. 19 and 20, seal components mayinclude handles for donning the seal components onto the liner bodyafter the liner body is already donned on the residual limb of the user.

FIG. 19 exemplifies a seal component 200 having opposed handles 204, 205that the user can grasp to pull the seal component 200 onto the linerbody against any resistance by the liner body cover and an interiorsurface 210 of the seal component. The interior surface 210 may includea plurality of inner rings 211 that provide resistance and are used tosecure against the liner body. The seal component 200 may include anupper portion 202 spacing the handles 204, 205 from the seal element208. A lower portion 206 extends below the seal element 208 and opens atthe bottom of the seal component 200.

FIG. 20 illustrates another embodiment of a seal component 220 havingthree handles 222 directly extending from the seal element 224. Thehandles may be constructed from a variety of different materials and maybe molded directly with the seal component or adhered, fastened orlocked on the liner body. The handles may be permanently fixed or fixedonly for the task of donning or doffing of the seal component. Thehandles may be formed differently from the seal component, and may beformed from a textile or different elastomeric such as polyurethane.

FIGS. 21 and 22 illustrate another seal component 300 having open upperand lower ends 314, 316, and an internal surface 326 for securing over aliner, as depicted in FIG. 23A generally using a liner 301 having the atleast one seal band 305. The internal surface 326 is arranged to engageand frictionally secure against the at least one seal band 26 on theliner 10 and forms through an opening 335 between the upper and lowerends 314, 316.

The seal component has an upper portion 302 with a curvature 306descending to a seal 304, and a lower portion 308 curvingly ascending tothe seal 304. The seal 304 extends from the lower portion 308 andextends a distance beyond the periphery of the curvature 306. The upperportion 302 defines a recess 310 formed by the periphery of thecurvature 306 proximate the seal 304, and a bevel 312 delimiting a topportion of the recess 310 from the curvature 306.

The lower portion 308 may define a plurality of ribs 318, 320, 322circumferentially extending around the periphery of the lower portion308. The ribs are arranged along the height of the lower portion 308 toimprove sealing with a socket wall. The ribs may have differentcross-sectional shapes, however in the preferred embodiment depicted inFIG. 21, the ribs have a curved cross-section.

The seal 304 is arranged to protrude away from a liner surface adistance 330 when not installed in a socket, and subsequently collapseagainst the liner surface when placed and engaging a socket, essentiallylosing the distance 330. The seal 304 forms a flap 324 protruding awayfrom the upper portion 302 a distance while having a base 328intersecting with the upper curvature 306. The flap 324 generally has asize corresponding to the recess 310 such that upon insertion into asocket, the flap 324 is urged into the recess 324, and has an endportion that may abut the bevel 312. The upper and lower portions 302,308 generally intersect at a base 328 of the flap 324.

Returning to FIG. 23A, the liner 301 has a liner body 303 in the shapeof a conical liner forming an axis A-A and having an outer surface 317.The liner body 303 may be formed similarly to the suspension liners ofFIGS. 1-4. The outer surface 317 includes a plurality of seal bands 305located along the height 307 of the liner body 303 and an outer surface317 of the liner body 303. The outer surface 317 may include indicia 331between or at each of the seal bands to advise the user whererecommended seal component placement may be located.

FIG. 23B discloses a cross-section of the suspension liner 300 of FIG.23A wherein the distal end defines a greatest thickness of the liner atlocation 307 (such as 9 mm). The thickness tapers from the distalportion with a thickness at location 311 (such 7 mm approaching themiddle portion), a thinner thickness at middle location 313, (such as3.2 mm) and a thinnest thickness at the proximal end at location 315(such as 2.5 mm).

FIGS. 24A-24C disclose the liner 301 of FIG. 23A and detail how the sealcomponent 300 of FIG. 21 secures to the liner and how the seal bands 305are formed.

Referring to FIG. 24B, the seal bands 319, 321, 323, 325 are providedalong the outer surface 317 of the liner body 303. The seal component300 preferably extends over at least one of the seal bands, wherein theexample of FIG. 24B shows the seal component 300 as extending over twoseal bands 319, 321. The seal bands 323, 325 outside the seal component300 are proximate the upper and lower ends of the seal component 300. Itis preferred to place the seal 304 proximate at least one of the sealbands since it is a location requiring firm engagement with the outersurface 317 of the liner body.

The seal component 300 may be configured and dimensioned to assure thatit extends over at least two seal bands over a corresponding liner toassure firm engagement of the seal component against the outer surface317 of the liner body 303. The seal component 300 is preferablytensioned over the seal bands and the liner over a residual limb suchthat the diameter of at least the ends of the upper and lower portions302, 308 are sized short of the diameter of the liner and/or the sealcomponent is stretched over the liner when the liner is worn on aresidual limb and tensioned over the liner.

FIG. 24C shows how the seal bands 305 protrude from the outer surface317 of the liner body. The seal bands 305 may define a variety of shapessuch as bubble, dome, arcuate, semi-hemispherical, square, and otheravailable shapes that may be molded over the liner body. FIG. 24Cdepicts a preferred shape defining a bubble or dome shape to facilitatemovement of the seal component of the seal bands.

The seal bands 305 are desirably arranged to bleed through a textilecover 327 forming the outer surface 317 of the liner body such that aportion 329 of the seal bands is located within the textile cover 327.The seal bands 305 extend through the textile cover 327 to a polymericmaterial layer 325 forming an interface to the residual limb of thewearer. The seal bands create an airtight interface between the linerand the seal component.

FIGS. 25A and 25B exemplify another seal component 400 having open upperand lower ends 414, 416, and an internal surface 426. The seal component400 can fit onto a liner similarly to the manner of the seal component300 to the liner 10.

The seal component 400 includes an upper portion 402 having a generallystraight profile corresponding to a liner periphery between a brim 412defined as arcuately extending upwardly away from the axis B-B towardthe upper end 414 and a transition portion 406 defined as arcuatelyextending downwardly away from the axis B-B toward a seal 404. The brim412 may collapse in part when the liner is inserted into a socket, andextends a distance 433 from the liner wall prior to insertion into asocket.

The seal 404 is located between the upper portion 402 and a lowerportion 408 extending upwardly from the lower end 416 and outwardly tothe seal 404. The lower portion 408 may have an arcuate cross-section ormay extend generally linearly toward the seal 404. The lower portion 408may define a plurality of ribs 418, 420, 422 circumferentially extendingaround the periphery of the lower portion 408, and may be arrangedsimilarly to the ribs in the seal component 300.

The seal 404 is formed as a flap 424 extending generally upwardly from aprofile of the lower portion 408, and at a junction 428 of thetransition portion 406 and the lower portion 408. The transition portion406 defines a collapsing region 410 adapted to extend from a linerperiphery a distance 430 prior to insertion of the liner in a socket.The interior surface 426 of the collapsing region 410 is generallyarranged to collapse against an outer wall of a liner when the liner isinserted into a socket, and crush against an interior wall of a socket.

The seal component 400 may include interior blades 432 located along theinterior surface 426 and correspond to the seal 404. The interior blades432 may be arranged obliquely to the axis B-B, and arranged to collapseagainst a liner exterior wall. The blades 432 may also reinforce theseal 404 to provide a stronger interface between the interior socketwall and the liner. The blades 432 may increase the interface betweenthe interior portion of the seal against the liner when collapsed in asocket.

The blades are arranged to compensate for volume changes in the residuallimb, by expanding and exerting pressure against an interior surface ofthe socket so as to improve suspension of the liner over knownsuspension liners with seals.

The blades are preferably arranged obliquely to the axis B-B, and thisarrangement permits the blades to expand outwardly as the liner isdonned onto the residual limb and fold down toward the seal wall withthe possibility of some overlap over each of the blades as the liner isdoffed. The blades are at an angle so as to ensure that each blade foldsin a proper predetermined direction so as to avoid the creation of anypressure points.

The blades are not limited to an obliquely extending configuration butmay be arranged in any number of configurations such as either generallyparallel or perpendicular relative to the longitudinal axis B-B of theliner.

FIGS. 26A and 26B show a variation of the seal component of FIGS. 21, 22and 25A. The seal component 500 includes upper, middle and lowerportions 502, 506, 508, respectively, with a seal 504 located near or atthe middle portion 506. The seal component 500 includes interior blades532, much arranged in the same manner as in the seal component 400 ofFIGS. 25A and 25B. The seal component 500 defines radial seals 518, 520located below the seal 504, and generally within the lower portion 508.

FIG. 26B exemplifies how the wall thickness of the seal component 500varies depending on the location. The thickness 550 at the lower portion508 and the thickness 552 of the seal 504 may be substantially uniform,such as at 1.0 mm, including along the flap 524. The uniform thicknesses550, 552 may be configured and dimensioned to provide improved strengthwithin the area of the seal and radial seals to assure firm sealingagainst a socket. The junction of the middle portion 506 and the seal504 may have an increased thickness 556 to accommodate collapse of theseal or the radial extension of the seal when the seal component isplaced in a socket. The upper portion 502 may have a progressivelysmaller thickness 556 as it approaches the proximal end 560 over theheight 554 of the seal component 500.

According to the embodiments of FIGS. 27-29B, an adjustable seal systemincludes a textile sleeve secured to an upper portion of the sealcomponent and arranged to radially compress against the outer surface ofthe liner. The textile sleeve is preferably an anatomical conformingfabric. The textile provides an interface for gripping, and therebyminimizing fine hand movement needed to don and adjust the sealcomponent over the liner. The seal component permits retrofitting overexisting liner without seal bands for low activity users, therebyenabling a user to decide between whether to use the seal component or aprosthetic sleeve, as taught by example in U.S. Pat. No. 6,592,539,granted Jul. 15, 2003, and incorporated herein by reference, to maintainconnection of the liner with a socket.

The seal component 600 has open upper and lower ends 614, 616 definingan opening 617 extending therethrough and an internal surface 626. Theseal component has an axis C-C arranged concentric with the axis A-A ofthe liner body. The internal surface 626 of the seal component isarranged to frictionally engage at least one of the plurality of sealbands 305 and secure on the outer surface 317 of the liner body 303. Theadjustable seal system further includes a sleeve 624 secured to theupper end 614 of the seal component 600 and arranged to radiallycompress against the outer surface 317 of the liner 301. The sleeve 624is preferably formed from a material different from the seal component600.

The sleeve 624 is preferably formed from a textile and the sealcomponent 600 is formed from a polymeric material, such as aninjection-molded silicone to form the definitive shape of the sealcomponent 600. The sleeve 624 is preferably more flexible and elasticthan the seal component 600 such that the sleeve 624 retracts to anoriginal size upon release of tension of the sleeve.

The sleeve 624 is preferably configured and dimensioned to securelytension over the liner. The sleeve 624 may have a diameter less than adiameter of the liner body 303 at the distal portion 20 such that thesleeve 624 stretches over and is tensioned when selectively placed overthe outer surface 317 of the liner body 303.

As shown in FIGS. 28A and 28B, the seal component 600 defines a body 601defining an interior surface 626 arranged to span a distance between atleast three seal bands 319, 321, 323 of the liner 301 and engagetherewith. While not limited to three seal bands 319, 321, 323, andwhile a single seal band may be envisioned, it is preferable to includeat least two seal bands to provide secure attachment regions to assurethe seal component 600 does not slip or provide disproportionateengagement of the seal bands.

The height of the seal component may be sized and configured to extendand engage with any number of seal bands, and the sleeve 624 may extendover at least one seal band 325, however due to the lesser rigidity, theseal component 600 primarily retains the seal component on the linerbody with the exception of the radial compression of the sleeve over theouter surface of the liner body.

The seal component 600 includes a seal 604 located below an upperportion 602 and above a lower portion 608, and generally at a middleportion 606. The upper portion concentric with the liner body 301 andthe seal 604 protruding radially outwardly from the axis C-C relative tothe upper portion 602. The seal 604 has a radially outermost portion orseal lip 615 arranged generally concentric with the upper portion 602.

The seal 604 has a lower segment 623 extending outwardly from the lowerportion 608 to the seal lip 615. The seal 604 has an upper segment 613extending inwardly from the seal lip 615 toward the upper portion 602. Aclearance 610 is defined between the upper portion 602 and the uppersegment 613 such that the seal 604 is arranged to be compressed againstthe upper portion 602. The seal 604 defines a flap 612 extending fromthe upper segment 613, and arranged generally parallel with the upperportion 602 and is spaced from the upper portion 602 by the clearance610.

The seal 604 may have a lower segment 623 extending outwardly from thelower portion 608 to the seal lip 615 and at least one radial seal 618,620, and preferably at least two radial seals, projecting outwardly fromthe lower segment 623. The seal lip and the radial seals are arranged tomaintain connection with the inner socket wall, thereby creating adistal vacuum chamber.

The seal component 600 may have a lower portion 608 defining a bottomedge with a curvature 621 and an upper portion 602 having asubstantially uniform diameter along its height. The lower portion 608may have a decreasing diameter toward the lower end 616, and is arrangedto be compressed against the liner when the seal component 600 is donnedthereon. The curvature at the bottom edge may be undersized to minimizemovement of the seal component when donning the socket.

The sleeve 624 may include at least one material section, and theexample of FIGS. 27 and 29A show the sleeve 624 as including a mainportion 625 having a first elasticity, and a top band 627 located at anupper end of the main portion 625 and having a second elasticity. Thetop band 627 may be sized and dimensioned to allow for being the primaryportion of the sleeve pulled by a user when donning the seal componenton a liner, although the user may likewise grip the main portion.

In any of the embodiments described herein, the shape of the sealcomponent may be conical or cylindrical to accommodate differentresidual limb shapes.

Any of the seal components may function by creating an airtight sealwith the liner body, and securely bond to the underlying liner due tocompressive cohesion of silicone upon silicone. Alternatively, the sealcomponent may be permanently adhered to the liner, or the seal componentmay be coated with a substance arranged to prevent bonding fromoccurring.

FIGS. 30A and 30B show a seal component 700 may be formed as a “donut”type structure. The seal component 700 may have a hollow center 702, toallow for easy donning onto the liner body and enabling the sealcomponent to roll onto the limb. The seal component 700 defines aplurality of radial seals 704 located about the periphery of the outersurface of the seal component 700 so as to provide a plurality ofpossible radial seals 704 against the or between the outer surface ofthe liner and the inner surface of the socket.

The radial seals 704 form peaks 706 and ridges 708, arranged not only sothe peaks 706 seal against the socket, but the ridges 708 assist theseal component in maintaining its shape as the seal component flattenswhen donned and pressed against the socket. When the residual limb isinserted onto the socket, the seal component 700 will compress due tothe hollow center 702, and create a secure seal via the radial seals704. The seal component 700 may be formed from a variety of materials,and preferably silicone.

In yet another embodiment, the seal component may be molded directlyonto a liner by way of a silicone adhesive or similar elastomericmaterial that is formed over the liner body. A mold may be providedallowing a clinician to directly mold the seal component to the linerbody. The molded seal component may adhere to the liner or may bedetachable therewith.

As shown in FIGS. 31A-31E, a method for placing a seal component 300 ona suspension liner 301 and securing therewith includes the stepsgripping the top of the liner and sliding over the hand until an innersurface is fully exposed. After exposing as much of the distal end ofthe liner as possible, the liner is positioned against the residual limband with light compression roll upward onto the limb. The liner isrolled all the way up the limb. The seal component 300 is pulled overthe distal end of the liner after the liner is donned on the limb and isselectively placed over the liner 301 at one of the seal bands. Alubricant spray 321 may be applied to facilitate donning of the linerand the prosthesis. The lubricant is preferably arranged to evaporatequickly after donning to maintain maximum suspension.

In each of the embodiments described herein, the adjustable seal systempermits optimal seal placement rather than a fixed seal placement asfound in many prior art seal systems. The seal components may be locatedaway from undercuts or shape irregularities defined by a residual limb.The seal height may be decided according to the user's needs, and theseal may be moved to adapt to various volume changes of the residuallimb.

The adjustable seal system embodiments require less effort when donningthe liner. For example, rather than deal with a permanent seal resistingdonning, the liner may be donned and then the seal may be selectivelyplaced along the height of the liner worn by the user.

The adjustable seal embodiments provide improved comfort for the user.The seal height may be decided according to the needs of the user, andsensitive areas may be avoided. The embodiments make it possible toprovide temporary relief of pressure below the seal. Because the seal isadjustable, the distal end of the liner may have improved conformabilitysince it does not require being configured with a permanent seal butrather is uninhibited by such structural limitations found in the priorart. For example, the embodiments of the adjustable seal system enableimproved proximal support since the liner may be arranged in a longerconfiguration over prior art liners, and improved proprioception may beobtained since the distal end may be arranged thinner with betterlinkage to the socket over prior art liners. Due to the seal bands ofthe liner, there is improved rotational control of the liner and sealrelative to the socket.

The adjustable seal embodiments may enable improved durability by havingbetter abrasion resistance due to the versatility in placement of theseal component and its separate yet non-permanent attachment to theliner.

While the foregoing embodiments have been described and shown,alternatives and modifications of these embodiments, such as thosesuggested by others, may be made to fall within the scope of theinvention. The principles described may be extended to other types ofprosthetic devices.

1. An adjustable seal system for providing an interface between aresidual limb and a prosthetic socket, comprising: a liner having aliner body forming an axis (A-A) and an outer surface, the outer surfaceincluding a plurality of seal bands located along the height of theliner body and an outer surface of the liner body; a seal componenthaving open upper and lower ends defining an opening therethrough and aninternal surface having an axis (B-B) arranged concentric with the axis(A-A) of the liner body, the internal surface arranged to frictionallyengage at least one of the plurality of seal bands and secure on theouter surface of the liner body.
 2. The adjustable seal system of claim1, wherein the liner defines a closed-ended distal portion, the sealcomponent is adapted to be inserted onto the liner from the distalportion.
 3. The adjustable seal system of claim 2, wherein the linerdefines an open-ended proximal portion having a greater diameter thanthe distal portion.
 4. The adjustable seal system of claim 3, wherein adiameter of the opening of the seal component is less than the diameterof the proximal portion of the liner body.
 5. The adjustable seal systemof claim 1, wherein the seal component has an upper portion having asegment with a curvature descending to a seal, and a lower portion has asegment curvingly ascending to the seal.
 6. The adjustable seal systemof claim 2, wherein the seal extends from the lower portion and adistance beyond the periphery of the curvature.
 7. The adjustable sealsystem of claim 5, wherein the upper portion defines a recess formed bythe periphery of the curvature proximate the seal, and a beveldelimiting a top portion of the recess from the curvature.
 8. Theadjustable seal system of claim 5, wherein the lower portion defines aplurality of ribs circumferentially extending around the periphery ofthe lower portion.
 9. The adjustable seal system of claim 1, furthercomprising a textile sleeve secured to an upper portion of the sealcomponent and arranged to radially compress against the outer surface ofthe liner.
 10. The adjustable seal system of claim 1, wherein the sealis arranged to protrude away from the outer surface of the liner body,and arranged to collapse against the outer surface when placed andengaging a socket, essentially losing the distance.
 11. The adjustableseal system of claim 1, wherein the seal forms a flap protruding awayfrom an upper portion of the seal component a distance while having abase intersecting with the upper curvature.
 12. The adjustable sealsystem of claim 11, wherein the upper portion defines a recess formed bythe periphery of the curvature proximate the seal, and a beveldelimiting a top portion of the recess from the curvature, the flapgenerally having a size corresponding to the recess such that uponinsertion into a socket, the flap is urged into the recess, and has anend portion that abutting the bevel.
 13. The adjustable seal system ofclaim 12, wherein the upper and lower portions generally intersect at abase of the flap.
 14. The adjustable seal system of claim 1, wherein theseal component defines interior blades located along the interiorsurface and correspond in location to the seal located on the exteriorside of the seal component.
 15. The adjustable seal system of claim 1,wherein the at least one seal band is formed from a polymeric materialand the outer surface of the liner body is defined by a textile cover,the at least one seal band extends through the textile cover andinterlocks therewith.
 16. A seal component for removably securing to asuspension liner for providing an interface between a residual limb anda prosthetic socket, the seal component comprising: open upper and lowerends defining an opening therethrough and an internal surface having anaxis (X-X) arranged concentric with the axis (A-A), the internal surfacearranged to frictionally engage at least one of the plurality of sealbands and secure on the outer surface of the liner body; an upperportion with a curvature descending to a seal, and a lower portioncurvingly ascending to the seal.
 17. The seal component of claim 16,wherein the seal extends from the lower portion and extends a distancebeyond the periphery of the curvature, the upper portion defining arecess formed by the periphery of the curvature proximate the seal, anda bevel delimiting a top portion of the recess from the curvature. 18.The adjustable seal system of claim 17, wherein the lower portiondefines a plurality of ribs circumferentially extending around theperiphery of the lower portion, the ribs are arranged along the heightof the lower portion.
 19. The adjustable seal system of claim 16,wherein the seal is arranged to protrude away from the outer surface ofthe liner body, and arranged to collapse against the outer surface whenplaced and engaging a socket, essentially losing the distance.
 20. Amethod for placing a seal component on a suspension liner and securingtherewith, comprising the steps of: providing a liner having a linerbody forming an axis (A-A) and having an outer surface, the outersurface including a plurality of seal bands located along the height ofthe liner body and an outer surface of the liner body; placing a sealcomponent having open upper and lower ends defining an openingtherethrough and an internal surface having an axis (X-X) arrangedconcentric with the axis (A-A) over the liner; securing the sealcomponent to the liner body by frictionally engaging the internalsurface with at least one of the plurality of seal bands.